Evaluation of the Pain Relief Effect of Battlefield Acupuncture on Patients With Chronic Low Back Pain Due to Lumbar Spine Degeneration.

Summary

The Global Burden of Disease's 2023 study shows that lower back pain affects over 619 million people worldwide, with projections reaching 843 million by 2050. It is a common symptom of lumbar spine degeneration, with 84.2% of patients experiencing it. To address this issue, Vietnam's Ministry of Health has released guidelines on "Lumbar Spine Pain" (Yêu thống), combining traditional and modern medicine, including acupuncture, to alleviate pain. However, to achieve better treatment outcomes, the combination of multiple interventions, such as different types of acupuncture, is required. Additionally, the USAF's Integrative Medicine and Acupuncture Center released guidelines in 2021 for Battlefield Acupuncture (BFA), a rapid, safe, and effective pain relief method. Internationally, there are studies on BFA for various types of pain, including lower back pain, but none in Vietnam. Therefore, the investigators conducted this study to evaluate the effects of BFA combined with electroacupuncture and pain medication on chronic lower back pain patients with lumbar spine degeneration in Vietnam.

Conditions

• Spondylosis Lumbar

Interventions

DEVICE

Ear acupuncture

(According to the guidelines provided in the "BFA - Acupuncture Manual" of the USAF Center for Integrative and Complementary Medicine.) Procedure: * Practitioner: Traditional medicine doctor with a practicing certificate. * Tools: Khanh Phong auricular acupuncture needles (license: 287/BYTYDCT) * Before needling: Disinfect the skin on both outer ears. * Insertion depth: Auricular needles penetrate the skin to a depth of 1.3 mm. Insert the auricular needles alternately on the right and left sides at the following acupoints: Cingulate gyrus, Subcortex, Omega 2, Shen Men, and Zero point. The insertion process stops when one of the following three criteria is met: (1) The patient experiences a 40% reduction in pain on the Visual Analog Scale (VAS), (2) The patient refuses to continue the insertion, or (3) A total of 10 needles have been inserted. * After needling: Patient may feel slight pain in the ear area or de qi (a sensation of aching, warmth, and redness at the needling site).

DEVICE

Electro-acupuncture

According to the "Guidelines for the Diagnosis and Treatment of Diseases by Traditional Medicine, combining Traditional Medicine with Modern Medicine" - 2020 - Ministry of Health of Viet Nam. Procedure: * Practitioner: Traditional medicine doctor with a practicing certificate. * Tools: Khánh Phong ARLO acupuncture needles, size 0.3 x 25 mm (lincense: TKHQ:102664344900) * Disinfect the lumbar region skin. * Needle insertion: Insert needles perpendicular to the patient's skin, to a depth of 20 mm. Location: Dai truong du (BL25), Than du (BL23), Jiaji at L4-L5, L5-S1 (Ex-B2), Uy trung (BL40), Yeu duong quan (GV3). After insertion, attach the electrode clips to the needle ends. * Electric stimulation: Use a current of 100Hz for 20 minutes - mixed wave. * Post-needling: Patient may feel a sensation of de qi (aching, warmth, and redness at the needling site).

DRUG

Paracetamol 500 mg

According to the "Guidelines for the Diagnosis and Treatment of Diseases by Traditional Medicine, combining Traditional Medicine with Modern Medicine" - 2020 - Ministry of Health of Viet Nam. * Prescriber: Traditional medicine doctor with a practicing certificate. * Paracetamol 500mg x 9 tablets: Take 1 tablet per dose, to be used when the pain score on the Visual Analog Scale (VAS) is ≥ 30mm, not exceeding 6 tablets/day. (If the patient still has medication from the previous visit, only prescribe the total amount needed to make up 9 tablets).

DEVICE

Sham ear acupuncture

Study uses patches with non-skin-penetrating cotton, at the intervention acupoint areas. Using acupoints matching with the intervention group helps reduce the patients' ability to predict their study group, and the non-penetrating and non-rotating cotton ensure that there is no analgesic effect on the lumbar area caused by auriculotherapy. Acupoint location: Cingulate gyrus, Subcortex, Omega 2, Shen Men, and Zero points

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-15

Primary Completion

2025-07-31

Completion

2025-08-31

Countries

• Vietnam

Study Locations